FDA Product Code
FDA Product Code CDW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1770
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K874532 | BLOOD UREA NITROGEN | Catachem, Inc. | 1988-01-05 | Traditional | PDF ↗ |
| K871320 | FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 | American Research Products Co. | 1987-04-22 | Traditional | PDF ↗ |
| K863425 | AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 | American Research Products Co. | 1986-10-01 | Traditional | PDF ↗ |
| K861775 | TWIN BUN/GLUCOSE | Boehringer Mannheim Corp. | 1986-06-27 | Traditional | PDF ↗ |
| K860419 | UREA NITROGEN REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K850937 | UREA | Dilab, Inc. | 1985-06-10 | Traditional | PDF ↗ |
| K844156 | UREA NITROGEN REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-13 | Traditional | PDF ↗ |
| K841068 | UREA NITROGEN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K822323 | ULTRACHEM BUN-UV, 65080 & 65081 | Harleco Diagnostics | 1982-09-02 | Traditional | PDF ↗ |
| K821212 | UREA NITROGEN REAGENT SET | Omega Medical Electronics | 1982-07-22 | Traditional | PDF ↗ |
| K813415 | UREA NITROGEN REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-31 | Traditional | PDF ↗ |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | Panmed, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K800673 | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K781885 | SERUM, BLOOD UREA NITIOGEN | Fisher Scientific Co., LLC | 1978-12-20 | Traditional | PDF ↗ |
| K781305 | UREA NITROGEN | Analytical & Research Chemicals, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K780262 | DIRECT UREA NITROGEN TEST | Hycel, Inc. | 1978-04-05 | Traditional | PDF ↗ |
| K771830 | BLOOD UREA NITROGEN BUN | Gamma Enterprises, Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771312 | BLOOD UREA NITROGEN (BUN) REAGENT | Mallinckrodt Critical Care | 1977-08-03 | Traditional | PDF ↗ |
| K771087 | UNIPAK BUN | Harleco | 1977-07-21 | Traditional | PDF ↗ |
| K770470 | WORTHINGTON BUN | Worthington Biochemical Corp. | 1977-06-02 | Traditional | PDF ↗ |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Simmler & Son, Inc. | 1976-10-29 | Traditional | PDF ↗ |
Product code CDW · Class II · Clinical Chemistry. Data: openFDA.